Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone

NCT06956794 | Active Not Recruiting

• 1 other identifier: 2024PROD00053
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effectiveness of an immersive virtual reality-based multimodal intervention (VirtualDONA) to improve cognitive health and emotional well-being in older women living alone and at risk of poverty. The intervention combines mindfulness, cognitive, and physical training in a group format over 8 weeks.

Conditions

Social Isolation in Older Adults; Poverty

Keywords

Social Isolation; Cognitive Dysfunction; Aging; Poverty; Virtual Immersive Reality

Outcome Measures

Primary Outcomes (13)

• Differences between groups in scores of global cognition

  Global cognition is assessed with the Mini-Mental State Examination (MMSE), a brief screening tool for cognitive impairment. The MMSE includes items that evaluate orientation, registration, attention and calculation, recall, language, and visuospatial ability. Scores range from 0 to 30, with higher scores indicating better cognitive function.

  Baseline and after the 8-week intervention

• Differences between groups in scores of global cognition

  Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of verbal episodic memory

  Verbal episodic memory is assessed with the Free and Cued Selective Reminding Test (FCSRT), which evaluates the ability to learn and recall words with both free and cued recall conditions. The total score ranges from 0 to 48, based on the number of words correctly recalled. Higher scores indicate better memory performance.

  Baseline and after the 8-week intervention

• Differences between groups in scores of auditory attention

  Auditory attention is measured with Digit Span Forward from WAIS-IV. Participants are asked to repeat numbers in the same order as read aloud by the examiner. Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of working memory

  Working memory is measured with Digit Span Backward from WAIS-IV. Participants are asked to repeat the numbers in the reverse order of that presented by the examiner. Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of processing speed

  Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Higher scores indicate better outcomes.

  Baseline and after the 8-week intervention

• Differences between groups in scores of visual scanning and processing speed

  Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of executive functioning and cognitive flexibility

  Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of executive functioning

  Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors indicate worse performance, while more categories completed reflect better executive functioning.

  Baseline and after the 8-week intervention

• Differences between groups in scores of selective attention, inhibition, and processing speed

  Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.

  Baseline and after the 8-week intervention

• Differences between groups in scores of phonetic fluency

  Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.

  Baseline and after the 8-week intervention

• Differences between groups in scores of semantic verbal fluency

  Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.

  Baseline and after the 8-week intervention

• Differences between groups in language

  Language function is assessed using the 15-item version of the Boston Naming Test (BNT), a confrontation naming task consisting of 15 black-and-white line drawings of objects with increasing difficulty. The total score is the number of correctly named items. Higher scores indicate better naming ability.

  Baseline and after the 8-week intervention

Secondary Outcomes (10)

• Differences between groups in scores of Quality of Life

  Baseline and after the 8-week intervention

• Differences between groups in scores of loneliness

  Baseline and after the 8-week intervention

• Differences between groups in scores of perceived social support

  Baseline and after the 8-week intervention

• Differences between groups in scores of emotional well-being

  Baseline and after the 8-week intervention

• Differences between groups in scores of depression

  Baseline and after the 8-week intervention

Other Outcomes (1)

• Qualitative user experience

  Within one week after the end of the 8-week intervention

Study Arms (2)

Immersive VR-Based Multimodal Intervention

EXPERIMENTAL

Participants in this arm will receive a multimodal, group-based intervention using immersive virtual reality without headsets. The intervention includes mindfulness, cognitive training, and physical exercises delivered in 16 group sessions over 8 weeks.

Behavioral: VirtualDONA Multimodal Program

Usual Activity (Control Group)

NO INTERVENTION

Participants in this arm will continue their usual daily routines with no specific intervention during the study period.

Interventions

VirtualDONA Multimodal Program BEHAVIORAL

A group-based behavioral intervention using immersive virtual reality without headsets. The 8-week program includes 16 sessions combining mindfulness, cognitive training, and physical exercises, designed to improve cognitive health and emotional well-being in older women living alone and at risk of poverty.

Immersive VR-Based Multimodal Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Female
• Age 65 years or older
• Living alone
• Registered with the elderly care services of Suara Cooperativa
• Annual income below the guaranteed minimum income threshold (below €20,353.62/year)
• Global cognitive functioning not suggestive of dementia, defined as MMSE score ≥ 24
• Able to read and write
• Good command of Catalan and/or Spanish
• Signed informed consent to participate in the study

You may not qualify if:

• History of severe neurological, psychiatric disorders, or intellectual disability
• Uncorrected sensory deficits (e.g., vision or hearing)
• Physical or motor impairments that may interfere with participation or bias outcome measures

Sponsors & Collaborators

• Suara Serveis SCCL: collaborator
• Consorci Sanitari de Terrassa: lead
• Broomx Technologies: collaborator

Study Sites (2)

SUARA Cooperativa

Barcelona, Barcelona, 08018, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Social Isolation; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maite Garolera, PhD

  Consorci Sanitari de Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Neuropsychological Unit and Director of the Brain, Cognition, and Behavior Research Group

Model Details: Randomized controlled trial with two parallel groups: one receiving a multimodal group-based intervention using immersive virtual reality, and a control group maintaining usual activities. The intervention consists of 16 sessions over 8 weeks.

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)